- The majority of patients being treated for solid tumour cancers were adequate responders to the vaccine.
- Serious adverse events occurred in 2% or less of all patients in the cancer-treatment cohorts.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Patients with cancer have an increased likelihood of developing severe COVID-19 infections. This study discusses the outcome of the mRNA-1273 COVID-19 vaccine on immunogenicity and safety in patients with cancer (solid tumour) receiving treatment as compared to those without cancer. Treatment modalities included either or both chemo- or immuno-therapy and study cohorts were classified as follows: individuals without cancer (A), cancer patients on immunotherapy (B), chemotherapy (C), or chemoimmunotherapy (D). A 100% response rate to the vaccine was observed on day 28 after the second dose in cohort A, a 99% response rate in cohort B, 97% in cohort C, and 100% in cohort D, supporting a conclusion of non-inferiority in each of the patient cohorts as compared to the control (A) based on statistical calculations. Using post-hoc analysis to categorize participants in each group into adequate, suboptimal, or non-responders found that 99% of cohort A, 93% of cohort B, 84% of cohort C, and 89% of cohort D were adequate responders at 28 days after the second dose. Patients receiving chemotherapy had the highest level of suboptimal or non-responders at 16%. The most prevalent local adverse event was pain where the vaccine was injected. The most prevalent systemic adverse effect noted was fatigue. Serious adverse events were uncommon and occurred in less than 2% of all cancer patient cohorts, and not at all in the control cohort (A). No vaccine-related deaths were reported. One particular limitation to this study is that its low-powered design prevents it from being able to inform on the impact of specific cancer treatments and their timing. Overall, patients with cancer who are receiving either immunotherapy, chemotherapy, or both, are mostly protected with two doses of the mRNA-1273 COVID-19 vaccination without great risk for severe adverse events.
In-Depth [prospective cohort]: This prospective, non-inferiority trial was based out of 3 clinical institutes in the Netherlands. 791 patients were included and divided into study cohorts A through D. Cohort A had 240 participants without cancer, cohort B had 131 cancer patients on immunotherapy, cohort C had 229 cancer patients on chemotherapy, and cohort D had 143 cancer patients on chemoimmunotherapy. Eligibility criteria for this study were adults with a life expectancy greater than 12 months. The primary endpoint of antibodies to SARS-CoV-2 at 28 days post-second vaccine was determined in 743 participants (per-protocol analysis; 240 from cohort A, 131 from cohort B, 229 from cohort C, and 143 from cohort D). Antibody concentration 28 days post-second dose of greater than 10 BAU/mL was measured in 100% of cohort A (95% confidence interval (CI), 98 to 100%), 99% of cohort B (95% CI, 96 to >99%), 97% of cohort C (95%, 94 to 99%), and 100% of cohort D (95% CI, 97 to 100%). Non-inferiority for all patient cohorts was reached based on a non-inferiority margin of 10% and an alpha value of 0.05. A post-hoc analysis differentiated cohort participants into adequate responders (>300 BAU/mL) and suboptimal responders (>10 BAU/mL to ≤300 BAU/mL). Adequate responders were found in greater than 99% of cohort A (95% CI, 98 to >99%), 93% of cohort B (95% CI, 87 to 97%), 84% of cohort C (95% CI, 78 to 88%), and 89% of cohort D (95% CI, 82 to 93%). Those who did not meet adequate response cutoff were categorized as suboptimal or non-responders. One of the secondary endpoints was safety, as indicated by adverse events. Adverse events were more frequent and of greater severity after the second vaccination as compared to the first. The most common systemic adverse event after the second dose was fatigue, reported in 54% of cohort A, 59% of cohort B, 49% of cohort C, and 48% of cohort D. Injection site pain was the most common local adverse event and was more frequent after the first than second vaccination in all cohorts. Post-second dose pain occurred in less than 10% of participants in all cohorts. Severe adverse events were reported in 0% of cohort A, 2% of cohort B, 2% of cohort C, and 1% of cohort D. The least common adverse events were injection site erythema and induration, occurring in less than 5% of participants in all cohorts. No new safety signals were reported compared to prior studies and no vaccine-related deaths occurred in any cohort.
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